{"type":"trials","record":{"id":42174,"source_id":"clinicaltrials-gov","external_id":"NCT04563299","title":"Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections","brief_summary":"This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injection visits. Treatment will be rendered at each injection visit based on the individualized routine established anti-VEGF injection interval for each patient.","overall_status":"Terminated","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Retina Vitreous Associates of Florida","enrollment":10,"countries":["United States"],"start_date":"2020-12-09","completion_date":"2023-02-14","last_update_date":"2023-02-22","source_url":"https://clinicaltrials.gov/study/NCT04563299","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Terminated. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"DETeR","age_range":"18 Years","comparator":"Topical Corticosteroids","organization":"Retina Vitreous Associates of Florida","interventions":["Dextenza 0.4Mg Ophthalmic Insert","Prednisolone Acetate"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean Change in Pain Scores — As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 d…","Overall Proportion of Eyes with Absence of AC Cell/Flare (Score of 0) — Assessed 3-6 days following Injection Visit 1,…","Proportion of eyes with absence of AC cells/flare (score of 0) — Assessed at 3-6 days following Injection Visit 1, Inje…","Correlation of pain scale outcomes with absence or presence of AC cell count and flare scores — Assessed at 3-6 days af…","Mean Change in pain scores — As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 d…","Patient Comfort — As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after I…","Mean Change in Tear Break-up Time — As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, Injection Visi…","Mean Change in Snellen and Pinhole Acuity — As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and In…","Mean change in IOP — As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and Injection Visit 3, and th…","Patient Preference — As assessed at the Final Post-Injection Follow-up Visit (up to 24 weeks)","Incidence and severity of adverse events — As assessed at Baseline, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), 3-6…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Diabetic Macular Edema","Retinal Vein Occlusion","Dextenza 0.4Mg Ophthalmic Insert","Prednisolone Acetate"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04563299","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-12-09 to 2023-02-14","comparator":"Topical Corticosteroids","confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.930Z","intervention":["Dextenza 0.4Mg Ophthalmic Insert","Prednisolone Acetate"],"participants":10,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Mean Change in Pain Scores — As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 d…","Overall Proportion of Eyes with Absence of AC Cell/Flare (Score of 0) — Assessed 3-6 days following Injection Visit 1,…","Proportion of eyes with absence of AC cells/flare (score of 0) — Assessed at 3-6 days following Injection Visit 1, Inje…","Correlation of pain scale outcomes with absence or presence of AC cell count and flare scores — Assessed at 3-6 days af…","Mean Change in pain scores — As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 d…","Patient Comfort — As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after I…","Mean Change in Tear Break-up Time — As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, Injection Visi…","Mean Change in Snellen and Pinhole Acuity — As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and In…","Mean change in IOP — As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and Injection Visit 3, and th…","Patient Preference — As assessed at the Final Post-Injection Follow-up Visit (up to 24 weeks)","Incidence and severity of adverse events — As assessed at Baseline, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), 3-6…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42174","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}